Dual Antiplatelet Therapy Over 6 Months Increases the Risk of Bleeding after Biodegradable Polymer‐Coated Sirolimus Eluting Stents Implantation: Insights from the CREATE Study

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  • FIfor the CREATE Investigators
    for the CREATE Investigators
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Abstract
Background: The optimal duration of dual antiplatelet therapy (DAPT) after drug‐eluting stent (DES) implantation remains controversial. The primary aim of our study was to evaluate the impact of optimal DAPT duration on bleeding events between 6 and 12 months after biodegradable polymer‐coated DES implantation. The secondary aim is to determine the predictors and prognostic implications of bleeding.Methods: This study is a post hoc analysis of the Multi‐Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents (CREATE) study population. A total of 2,040 patients surviving at 6 months were studied, including 1,639 (80.3%) who had received 6‐month DAPT and 401 (19.7%) who had received DAPT greater than 6 months. Bleeding events were defined according to the bleeding academic research consortium (BARC) definitions as described previously and were classified as major/minor (BARC 2–5) and minimal (BARC 1). A left censored method with a landmark at 6 months was used to determine the incidence, predictors, and impact of bleeding on clinical prognosis between 6 and 12 months.Results: At 1‐year follow‐up, patients who received prolonged DAPT longer than 6 months had a significantly higher incidence of overall (3.0% vs. 5.5%, P = 0.021) and major/minor bleeding (1.1% vs. 2.5%, P = 0.050) compared to the patients who received 6‐month DAPT. Multivariate analysis showed that being elderly (OR = 1.882, 95% CI: 1.109–3.193, P = 0.019), having diabetes (OR = 1.735, 95% CI: 1.020–2.952, P = 0.042), having a history of coronary artery disease (OR = 2.163, 95% CI: 1.097–4.266, P = 0.026), and duration of DAPT longer than 6 months (OR = 1.814, 95% CI: 1.064–3.091, P = 0.029) were independent predictors of bleeding. Patients with bleeding events had a significantly higher incidence of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis.Conclusions: Prolonged DAPT (greater than 6 months) after biodegradable polymer‐coated DES increases the risk of bleeding, and is associated with adverse cardiac events at 1‐year follow‐up. (J Interven Cardiol 2014;27:119–126)

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